How the reference price system may apply for products with the same active ingredient but different potency
Judgement of the Supreme Court of 27 October 2021
Capsulas Nº 221
Background We are approaching the 25th anniversary of the reference pricing system (RPS), which was first introduced in Spain by Law no. 13/1996. Hindsight allows us to draw one conclusion, among others: while the RPS has proved to be a useful tool to control pharmaceutical expenditure and ensure sustainability of the public healthcare system, applying... Read More
Any unsuccessful tenderer can access documents related to the performance of a public contract
The judgment of the Spanish National High Court of 1 October 2021 contends that the way in which a contract is performed affects public interest
Capsulas Nº 221
Background The judgment under analysis derives from Resolution no. 122/2019, of 25 March, of the Council of Transparency and Good Governance (CTBG, according to its Spanish acronym). A company that submitted a bid in the context of a public tender and was not awarded the contract requested the Ministry of Public Works and Transport to... Read More
No time limit applies to appeals against de facto material actions or administrative inactivity
Judgment of the Supreme Court of 1 October 2021
Capsulas Nº 221
Appeals against de facto material actions Appeals against material actions of the Public Administration without any legal basis, also known as de facto material actions, illustrate how the classical view of administrative courts as mere reviewers of administrative acts may be overcome. Two alternatives arise in the case of a de facto material action (articles... Read More
Four lawyers of Faus & Moliner appear in the Best Lawyers Guide 2022 in Spain
Jordi Faus, Xavier Moliner, Eduard Rodellar y Verónica Carias recognized in the guide The Best Lawyers in Spain
The legal guide The Best Lawyers in Spain has recently launched its edition for the year 2022, in which, on the basis of nominations by professional collegues, made through the website of Best Lawyers, the main lawyers and firms are identified and classified according with the practice areas and the geographic region. The process begins... Read More
La regulación autonómica de la visita médica: un terreno movedizo
El Global
El pasado jueves se publicó en el BOPV la resolución del Director de Régimen Jurídico, Económico y Servicios Generales del Departamento de Salud del País Vasco relativa a la publicación de la famosa Sentencia del TSJ de esta comunidad, de 30 de junio de 2021, que anulaba varios artículos de la Orden vasca sobre la... Read More
Preguntas y respuestas
El Global
En las democracias parlamentarias, los diputados y senadores tienen la potestad de formular preguntas al gobierno. Se supone que esto forma parte de los mecanismos de control del gobierno. Digo “se supone” porque francamente, en muchas ocasiones, las preguntas parlamentarias dejan mucho que desear. Por otro lado, ¿qué se puede decir de las respuestas? Seguramente,... Read More
Faus & Moliner participates once again in the chapter on pharmaceutical law regarding Spain in the Practical Law guide published by Thomson Reuters
Jordi Faus, Xavier Moliner, Eduard Rodellar, Lluís Alcover, Santiago Tomás, Anna Gerbolés and Juan Martínez write the chapter on Regulation and Product Liability in Spain: Overview
The guide, in a Q&A format, provides a description of the most relevant issues related to the regulation of medicines in Spain, including, among others, matters related to research and development, manufacturing, pricing and financing conditions, marketing, advertising, and product recall and liability.
La experiencia es la madre de la ciencia
El Global
Permítanme que en esta ocasión me tome la libertad de echar mano de nuestro refranero, fuente de sabiduría popular, para ponerle título a este artículo de opinión. Lo hago para destacar la importancia que considero tiene la experiencia en todo conocimiento. Esto es lo que sucede con los “Datos de la Vida Real” (Real World... Read More
El caso de las vacunas y alérgenos preparados individualmente
El Global
La semana pasada tuve el placer de participar, virtualmente, en un Simposio Satélite en el marco del 33º Congreso de la Sociedad Española de Alergología e Inmunología Clínica, en el cual se trató sobre el tema de la preparación individualizada de vacunas y alérgenos para un solo paciente. Esta es una de las excepciones, previstas... Read More
Sobre nanomedicinas
El Global
Esta semana he tenido la oportunidad de participar en un Simposium sobre nanomedicinas en el 66 Congreso de la SEFH, presentando una breve ponencia sobre el marco regulatorio de las mismas. Uno de los grandes retos a los que se enfrenta el legislador al redactar una norma es el de las definiciones. Recuerdo bien cuando... Read More